NCT04165811

Brief Summary

In this study, our primary aim is; investigate the effect of aerobic dance based exercise program on lower extremity functions (walking, stair stroke climbing, etc.) in obese individuals awaiting bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

November 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 11, 2022

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

November 14, 2019

Last Update Submit

May 10, 2022

Conditions

Keywords

bariatric surgeymorbid obesityaerobic exerciselower extremity functions

Outcome Measures

Primary Outcomes (2)

  • Six Minute Walk Test

    The Six Minute Walk Test was conducted according to a standardized protocol, using an internal hallway with the 30-meter distance marked by colored tape on the floor. Participants will be told that "the purpose of this test is to see how far you can walk in six minutes." Then, they will be instructed to "walk from end to end of the hallway at your own pace, in order to cover as much ground as possible." Participants will be allowed to stop and rest during the test, but will be instructed to resume walking as soon as they were able to do so. Before the walk started and at the end of the 6-min walk, participants will be shown a modified Borg dyspnea scale printed on a card and asked to "indicate your current degree of shortness of breath" on a scale of "0 = nothing at all" to "10 = very, very severe." At the end of the walk, they will be asked if they had experienced any of the following specific symptoms: dyspnea, chest pain, light-headedness, or leg pain, or any other symptoms.

    Change from baseline to 8 weeks follow up at two months and post-op 5 months

  • Biodex Isokinetic Muscle Strength Measurement

    sokinetic device. In all cases; In accordance with the test measurement protocol, both the Quadriceps Femoris and the Hamstring muscle strength were concentric contraction, primarily 5 repetitions at 60 ° / sec; then 10 repetitions at a rate of 240° / sec. After each limb measurement, a rest interval of 2 minutes will be given. Peak torque will be recorded in Newtonmeters / kilograms (Nm / kg)

    Change from baseline to 8 weeks follow up at two months and post-op 5 months

Secondary Outcomes (6)

  • Bioelectrical Impedance Analysis-obesity score

    Change from baseline to 8 weeks follow up at two months and post-op 5 months

  • Biodex Balance System-Fall Risk Test

    Change from baseline to 8 weeks follow up at two months and post-op 5 months

  • Evaluation of physical activity

    Change from baseline to 8 weeks follow up at two months and post-op 5 months

  • Sit and Up Test

    Change from baseline to 8 weeks follow up at two months and post-op 5 months

  • Stair Climbing Test

    Change from baseline to 8 weeks follow up at two months and post-op 5 months

  • +1 more secondary outcomes

Study Arms (2)

Aerobic Dance based Exercise

EXPERIMENTAL

The exercise program will be administered 60 minutes, 2 days a week for 8 weeks. The exercise program will be created by physiotherapists as a group exercise program.

Other: Exercise treatment

Counseling of physical activity

EXPERIMENTAL

Physical activity counseling is aimed at increasing the physical activity levels of the individuals who are waiting for bariatric surgery in the preoperative period.

Other: Counselling

Interventions

A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.

Also known as: Aerobic dance based exercise
Aerobic Dance based Exercise

Only physical activity counseling will be given to the subjects in this group.

Also known as: Counseling of physical activity
Counseling of physical activity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged between 18-65
  • Body mass index ≥40 or ≥35 with concomitant diseases
  • No surgical operation in the last 6 months

You may not qualify if:

  • Musculoskeletal disorders or systemic diseases that may prevent exercise
  • The presence of psychiatric or neurological disease affecting cooperation and cognitive functions
  • Presence of acute pain
  • Heart pain
  • Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension
  • Regular exercise for 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, MorbidMotor ActivityObesity

Interventions

Counseling

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gülfidan Tokgöz

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

November 30, 2019

Primary Completion

January 30, 2020

Study Completion

June 30, 2020

Last Updated

May 11, 2022

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations